What does Preamble of Biosimilar Red Tape Elimination Act do?

This bill aims to improve the requirements for determining the interchangeability of a biological product and its reference product.

What does SHORT TITLE. of Biosimilar Red Tape Elimination Act do?

This bill is formally titled the Biosimilar Red Tape Elimination Act.

What does BIOSIMILAR BIOLOGICAL PRODUCTS. of Biosimilar Red Tape Elimination Act do?

This section amends Section 351(k) of the Public Health Service Act to modify requirements related to biosimilar biological products. The amendments adjust the structure of existing paragraphs and subclauses within Section 351(k), redesignating certain elements. The legislation establishes a 'transition date,' 60 days after enactment, impacting when a biological product is deemed interchangeable. It clarifies the conditions under which a biological product is considered interchangeable with a reference product, particularly concerning licensure dates and exclusivity periods. The bill modifies provisions related to first interchangeable exclusivity periods for certain biological products. Several conforming amendments are made to other sections of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. The Secretary is directed to update existing guidance documents related to biosimilar biological products within 18 months of the Act's enactment.

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Biosimilar Red Tape Elimination Act

Last updated: 6/17/2026 · Introduced: 6/4/2025

Author: Mike Lee (R-UT)

TL;DR (AI)

This bill modifies requirements for determining when a biological product is interchangeable with a reference product, establishing a transition date 60 days after enactment.
The legislation clarifies conditions for a biological product to be considered interchangeable, specifically addressing licensure dates and exclusivity periods.
The bill directs the Secretary to update guidance documents related to biosimilar biological products within 18 months of enactment.

119th Congressin committeeHR. 5526(In Committee)Official page

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Other Sections

Includes provisions on preamble, short title., and 1 more.

3 sections

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